Some cantons pushed through quickly and were very careful about that. For example, the vaccination centers in Lucerne yesterday temporarily suspended the vaccination of the new bivalent vaccine from Pfizer/Biontech because bubbles have formed in the syringes. However, the Swissmedic Therapeutic Products Authority has not banned the Comirnaty Bivalent Original/Omicron BA.1 vaccine at all, but has recommended additional visual checks as a precautionary measure before vaccination and storage of the filled syringes for up to 15 minutes.
This was preceded by a notification of a quality defect that was reported in the normal procedure of the medicines authority, which is responsible for the safety of medicines and vaccines. “After such a report of a quality defect in a medicine, we have to immediately check whether there is a risk,” says Lukas Jaggi of Swissmedic.
Tests have therefore been carried out in Swissmedic’s own laboratory to determine whether there is a risk of this bubble formation. And also where the cause of the detected defect could come from. For the study, Swissmedic received samples from the affected vaccination centers to analyze in the laboratory.
Depending on the outcome of such an investigation in the Swissmedic laboratory, measures can then be taken. “The test is a standard process,” says Jaggi. There are many such reports every year, up from 886 last year. There were 21 drug recalls, three veterinary drugs and 18 human drugs. The most egregious case is when the shortage of the drug puts patients directly at risk. Then you have to act quickly to prevent them from using them.
The pharmaceutical companies then have to place advertisements in the media to, for example, provide information about the shortage of the drug. As an example, Jaggi cites a broken glass thread on a container for a strong narcotic. The glass thread broke off when opening the bottle, which could endanger patients. The drug therefore had to be recalled from patients. According to Swissmedic, there are about 5 to 6 such recalls per year.
However, in the case of the bubbles in the Pfizer vaccine, it certainly won’t come to that. “The lab tests show there is no evidence of any specific problems with the vaccine,” said Alex Josty of Swissmedic. The bubbles in the filled syringe are the result of a different application of the new bivalent vaccine.
The conventional Covid mRNA vaccines had to be thawed and diluted before vaccination. “Now all you have to do is thaw the vaccine, pull it into the syringe, and vaccinate it,” says Josty. And during the thawing process of this application, bubbles may form in the syringe or in the vial. The formation of bubbles has physical causes and also has to do with the changing air and temperature differences when using the vaccine.
A physical process is taking place that can also be seen in other places. If you put a glass of water on the desk, air bubbles will also form in the glass over time. This process can also occur in other liquids and vaccines. This poses no threat to the vaccinated person. Swissmedic advises the vaccination centers to carry out the vaccinations in accordance with the information for healthcare professionals to avoid blisters. There is no reason to continue to suspend vaccinations. Swissmedic continues to analyze the situation and is investigating all reported cases. (aargauerzeitung.ch)
source: watson
I’m Maxine Reitz, a journalist and news writer at 24 Instant News. I specialize in health-related topics and have written hundreds of articles on the subject. My work has been featured in leading publications such as The New York Times, The Guardian, and Healthline. As an experienced professional in the industry, I have consistently demonstrated an ability to develop compelling stories that engage readers.
